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821. Notifying CDRH of a permanent discontinuance or interruption in manufacturing of a device under Section 506J of the FD&C Act during the COVID-19 public health emergency (revised): guidance for industry and Food and Drug Administration staff

Publication:: [Silver Spring, MD] : Center for Devices and Radiological Health, November 2020
Subject(s):: Equipment and Supplies
Manufacturing Industry
Medical Device Legislation
COVID-19
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

822. VA acquisition management: actions needed to improve management of medical-surgical prime vendor program and inform future decisions : report to Congressional requesters

Publication:: Washington, DC : United States Government Accountability Office, September 2020
Subject(s):: Equipment and Supplies -- economics
Government Regulation
Veterans
United States
United States. Department of Veterans Affairs

823. Qualification process for drug development tools: guidance for industry and FDA staff

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, November 2020
Subject(s):: Drug Approval
Drug Development -- methods
Drug Development -- standards
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

824. Formal meetings between FDA and ANDA applicants of complex products under GDUFA

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, November 2020
Subject(s):: Drug Approval
Drug Development
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

825. VA health care: actions needed to ensure provider qualifications and competence : testimony before the Subcommittee on Oversight and Investigations, Committee on Veterans' Affairs, House of Representatives

Publication:: Washington, DC : United States Government Accountability Office, October 2019
Subject(s):: Credentialing
Facility Regulation and Control
Government Regulation
Veterans -- legislation & jurisprudence
United States
United States. Department of Veterans Affairs

826. Regulatory considerations for microneedling products: guidance for industry and Food and Drug Administration staff

Publication:: [Silver Spring, MD] : Center for Devices and Radiological Health, November 10, 2020
Subject(s):: Medical Device Legislation
Needles -- standards
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

827. Enhancing the diversity of clinical trial populations: eligibility criteria, enrollment practices, and trial designs

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, November 2020
Subject(s):: Biological Variation, Population
Clinical Trial Protocols as Topic
Clinical Trials as Topic
Population Characteristics
Cultural Diversity
Genetic Variation
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

828. Assessing user fees under the prescription drug user fee amendments of 2017

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, November 2020
Subject(s):: Drug Approval
Prescription Drugs
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

829. Medicaid demonstrations: actions needed to address weaknesses in oversight of costs to administer work requirements : report to Congressional requesters

Publication:: Washington, DC : United States Government Accountability Office, October 2019
Subject(s):: Employment -- legislation & jurisprudence
Government Regulation
Medicaid -- legislation & jurisprudence
United States

830. Workforce Innovation And Opportunity Act: additional DOL actions needed to help states and employers address substance use disorder : report to Congressional requesters

Publication:: Washington, DC : United States Government Accountability Office, May 2020
Subject(s):: Financing, Government -- organization & administration
Government Regulation
Opioid-Related Disorders -- economics
Workforce -- legislation & jurisprudence
United States
United States. Department of Labor

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